Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
- Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high
grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of
complete and partial response rate in patients with postoperative measurable disease,
and in terms of the rate of freedom from recurrence in patients with no postoperative
- Determine the 3 year overall and progression free survival rates in this patient
population when treated with adjuvant irinotecan followed by radiotherapy and
- Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this
OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on
weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan
and if appropriate, patients may undergo a second surgical resection.
Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second
resection, patients receive image guided external beam radiotherapy 5 days per week for 6
weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost
At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5
days. Treatment repeats every 3 weeks for 6 courses.
Patients are followed every 3 months for 2 years, then every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.
Primary Purpose: Treatment
Amar Gajjar, MD
St. Jude Children's Research Hospital
United States: Federal Government
|Saint Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|